Thérapies basées sur les incrétines pour la prévention des événements cardiovasculaires chez les patients avec et sans ASCVD (INTERCEPT-ASCVD) (INTERCEPT)
9 mai 2026 mis à jour par: Shirley Vichy Wang, Brigham and Women's Hospital
Efficacité comparative du dulaglutide, du sémaglutide et du tirzepatide dans la prévention des événements cardiovasculaires chez les patients atteints de diabète de type 2 et d'obésité, avec ou sans maladie cardiovasculaire athérosclérotique.
Les investigateurs constituent une base de preuves empiriques pour les données du monde réel grâce à une émulation à grande échelle d'essais contrôlés randomisés.
L'objectif des investigateurs est de comprendre pour quels types de questions cliniques les analyses de données du monde réel peuvent être menées avec confiance et comment mettre en œuvre de telles études.
Aperçu de l'étude
Statut
Actif, ne recrute pas
Les conditions
Intervention / Traitement
Description détaillée
Il s'agit d'une étude non randomisée et non interventionnelle qui fait partie de l'initiative Randomized Controlled Trials Duplicated Using Prospective Longitudinal Insurance Claims: Applying Techniques of Epidemiology (RCT-DUPLICATE) (www.rctduplicate.org) du Brigham and Women's Hospital, Harvard Medical School. Les essais contrôlés randomisés (ECR) ont démontré les bénéfices cardiovasculaires des thérapies incrétines modernes, le sémaglutide et le tirzépatide, dans des populations sélectionnées. SUSTAIN-6 (NCT01720446) et SURPASS-CVOT (NCT04255433) ont montré des réductions des événements cardiovasculaires avec le sémaglutide et le tirzépatide chez des patients atteints de diabète de type 2 (DT2) à haut risque cardiovasculaire, des résultats qui ont également été reproduits en pratique clinique (NCT06659744, NCT07088718).1-3 L'essai REWIND (NCT01394952) a démontré une efficacité cardiovasculaire similaire pour le dulaglutide et a suggéré un bénéfice à la fois chez les patients avec et sans maladie cardiovasculaire antérieure.4 Ces résultats soulèvent la question plus large de savoir si les bénéfices cardiovasculaires des thérapies incrétines modernes s'étendent aux individus sans maladie cardiovasculaire athérosclérotique (MCVAS) établie lorsqu'elles sont utilisées en pratique clinique courante.
Pour répondre à cette question, cette étude d'efficacité comparative utilisant un cadre d'émulation d'essai cible évaluera les thérapies incrétines dulaglutide, sémaglutide et tirzépatide par rapport au sitagliptine (utilisé comme proxy placebo comparateur actif) sur les événements cardiovasculaires indésirables majeurs (MACE) chez les individus atteints de diabète de type 2 (DT2) et en surpoids avec ou sans MCVAS.
Bien que de nombreuses caractéristiques de l'essai cible ne puissent être directement reproduites dans les données de réclamations de soins de santé, les mesures des caractéristiques clés de la conception, y compris les critères de jugement, les expositions et les critères d'inclusion/exclusion, ont été conçues pour se substituer à ces caractéristiques de l'essai cible. La randomisation ne peut être obtenue dans les données de réclamations de soins de santé mais a été approchée par un équilibrage statistique des covariables mesurées selon la pratique standard.
Les analyses de bases de données seront des études comparatives actives de nouveaux utilisateurs, menées à l'aide de 3 bases de données nationales américaines de réclamations, où nous comparons l'effet du dulaglutide, du sémaglutide et du tirzépatide par rapport au sitagliptine sur la prévention des événements cardiovasculaires athérosclérotiques.
Type d'étude
Observationnel
Inscription (Estimé)
60000
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Lieux d'étude
-
-
Massachusetts
-
Boston, Massachusetts, États-Unis, 02120
- Brigham and Women's Hospital
-
-
Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
N/A
Méthode d'échantillonnage
Échantillon non probabiliste
Population étudiée
Personnes atteintes de T2DM et en surpoids avec (ou sans) ASCVD.
La description
Les analyses de la base de données seront des études comparatives actives de nouveaux utilisateurs, menées à l'aide de 3 bases de données de réclamations nationales des États-Unis, où nous comparons l'effet du dulaglutide, du sémaglutide et du tirzepatide par rapport au sitagliptin sur la prévention des événements cardiovasculaires athérosclérotiques.
Optum : période d'entrée dans la cohorte éligible du 18 septembre 2014 au 31 août 2025. Marketscan : entrée dans la cohorte éligible du 1er octobre 2016 au 31 octobre 2023. Medicare : entrée dans la cohorte éligible du 18 septembre 2014 au 31 octobre 2020.
POPULATION AVEC ASCVD
Critères d'inclusion :
- Antécédents d'ASCVD (définis comme IM, SCA, angor stable/instable, procédure de revascularisation coronarienne/autre artérielle chirurgicale ou percutanée, AVC ischémique, AIT, anévrisme aortique, maladie artérielle périphérique)
- IMC >= 25,0 kg/m²
- Diabète de type 2
Critères d'exclusion :
- Carcinome médullaire de la thyroïde
- Syndrome MEN de type 2
- Malignité
- Diabète de type 1 ou diabète secondaire
- Maladie rénale terminale ou dialyse
- Rétinopathie ou maculopathie diabétique non contrôlée
- Grossesse
- Chirurgie bariatrique
- Utilisation antérieure de pramlintide, ou de tout agoniste des récepteurs du GLP-1 à l'exception du sémaglutide/tirzepatide/dulaglutide injectable, ou de tout inhibiteur de la DPP4 à l'exception du sitagliptin
- Événement ou intervention cardiovasculaire
- Utilisation concomitante des deux médicaments de l'étude
POPULATION SANS ASCVD
Critères d'inclusion :
- IMC >= 25,0 kg/m²
- Diabète de type 2
Critères d'exclusion :
- Antécédents d'ASCVD (définis comme IM, SCA, angor stable/instable, procédure de revascularisation coronarienne/autre artérielle chirurgicale ou percutanée, AVC ischémique, AIT, anévrisme aortique, maladie artérielle périphérique)
- Carcinome médullaire de la thyroïde
- Syndrome MEN de type 2
- Malignité
- Diabète de type 1 ou diabète secondaire
- Maladie rénale terminale ou dialyse
- Rétinopathie ou maculopathie diabétique non contrôlée
- Grossesse
- Chirurgie bariatrique
- Utilisation antérieure de pramlintide, ou de tout agoniste des récepteurs du GLP-1 à l'exception du sémaglutide/tirzepatide/dulaglutide injectable, ou de tout inhibiteur de la DPP4 à l'exception du sitagliptin
- Utilisation concomitante des deux médicaments de l'étude
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
Cohortes et interventions
Groupe / Cohorte |
Intervention / Traitement |
|---|---|
|
Initiation du dulaglutide, du semaglutide ou du tirzepatide
Groupe d'exposition.
|
L'initiation de la demande de dispensation du dulaglutide est utilisée comme l'exposition.
L'initiation de la réclamation de délivrance de sémaglutide est utilisée comme exposition.
L'initiation de la demande de dispensation de tirzepatide est utilisée comme exposition.
|
|
Initiation de la sitagliptine
Groupe de référence.
|
L'initiation de la demande de dispensation de sitagliptine est utilisée comme référence.
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Composite of myocardial infarction, stroke, or all-cause mortality (with ASCVD)
Délai: Through study completion until first of outcome, disenrollment, end of study period, 365 days after cohort entry, discontinuation (45 days grace and risk window), switch between study arms, nursing home admission, or start of any other GLP-1-RA or DPP4i
|
Hazard ratio of the composite of myocardial infarction, stroke, or all-cause mortality in individuals with T2DM and overweight with ASCVD, comparing dulaglutide, semaglutide, and tirzepatide vs sitagliptin.
|
Through study completion until first of outcome, disenrollment, end of study period, 365 days after cohort entry, discontinuation (45 days grace and risk window), switch between study arms, nursing home admission, or start of any other GLP-1-RA or DPP4i
|
|
Composite of myocardial infarction, or stroke (with ASCVD)
Délai: Through study completion until first of outcome, disenrollment, end of study period, 365 days after cohort entry, discontinuation (45 days grace and risk window), switch between study arms, nursing home admission, or start of any other GLP-1-RA or DPP4i
|
Hazard ratio of the composite of myocardial infarction or stroke in individuals with T2DM and overweight with ASCVD, comparing dulaglutide, semaglutide, and tirzepatide vs sitagliptin.
|
Through study completion until first of outcome, disenrollment, end of study period, 365 days after cohort entry, discontinuation (45 days grace and risk window), switch between study arms, nursing home admission, or start of any other GLP-1-RA or DPP4i
|
|
Composite of myocardial infarction, stroke, or all-cause mortality (without ASCVD)
Délai: Through study completion until first of outcome, disenrollment, end of study period, 365 days after cohort entry, discontinuation (45 days grace and risk window), switch between study arms, nursing home admission, or start of any other GLP-1-RA or DPP4i
|
Hazard ratio of the composite of myocardial infarction, stroke, or all-cause mortality in individuals with T2DM and overweight without ASCVD, comparing dulaglutide, semaglutide, and tirzepatide vs sitagliptin.
|
Through study completion until first of outcome, disenrollment, end of study period, 365 days after cohort entry, discontinuation (45 days grace and risk window), switch between study arms, nursing home admission, or start of any other GLP-1-RA or DPP4i
|
|
Composite of myocardial infarction, or stroke (without ASCVD)
Délai: Through study completion until first of outcome, disenrollment, end of study period, 365 days after cohort entry, discontinuation (45 days grace and risk window), switch between study arms, nursing home admission, or start of any other GLP-1-RA or DPP4i
|
Hazard ratio of the composite of myocardial infarction or stroke in individuals with T2DM and overweight without ASCVD, comparing dulaglutide, semaglutide, and tirzepatide vs sitagliptin.
|
Through study completion until first of outcome, disenrollment, end of study period, 365 days after cohort entry, discontinuation (45 days grace and risk window), switch between study arms, nursing home admission, or start of any other GLP-1-RA or DPP4i
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Myocardial infarction (with ASCVD)
Délai: Through study completion until first of outcome, disenrollment, end of study period, 365 days after cohort entry, discontinuation (45 days grace and risk window), switch between study arms, nursing home admission, or start of any other GLP-1-RA or DPP4i
|
Hazard ratio of the occurrence of myocardial infarction in individuals with T2DM and overweight with ASCVD, comparing dulaglutide, semaglutide, and tirzepatide vs sitagliptin.
|
Through study completion until first of outcome, disenrollment, end of study period, 365 days after cohort entry, discontinuation (45 days grace and risk window), switch between study arms, nursing home admission, or start of any other GLP-1-RA or DPP4i
|
|
Stroke (with ASCVD)
Délai: Through study completion until first of outcome, disenrollment, end of study period, 365 days after cohort entry, discontinuation (45 days grace and risk window), switch between study arms, nursing home admission, or start of any other GLP-1-RA or DPP4i
|
Hazard ratio of the occurrence of stroke in individuals with T2DM and overweight with ASCVD, comparing dulaglutide, semaglutide, and tirzepatide vs sitagliptin.
|
Through study completion until first of outcome, disenrollment, end of study period, 365 days after cohort entry, discontinuation (45 days grace and risk window), switch between study arms, nursing home admission, or start of any other GLP-1-RA or DPP4i
|
|
All-cause mortality (with ASCVD)
Délai: Through study completion until first of outcome, disenrollment, end of study period, 365 days after cohort entry, discontinuation (45 days grace and risk window), switch between study arms, nursing home admission, or start of any other GLP-1-RA or DPP4i
|
Hazard ratio of the occurrence of all-cause mortality in individuals with T2DM and overweight with ASCVD, comparing dulaglutide, semaglutide, and tirzepatide vs sitagliptin.
|
Through study completion until first of outcome, disenrollment, end of study period, 365 days after cohort entry, discontinuation (45 days grace and risk window), switch between study arms, nursing home admission, or start of any other GLP-1-RA or DPP4i
|
|
Composite of myocardial infarction, stroke, hospitalization for unstable angina, or coronary revascularization (with ASCVD)
Délai: Through study completion until first of outcome, disenrollment, end of study period, 365 days after cohort entry, discontinuation (45 days grace and risk window), switch between study arms, nursing home admission, or start of any other GLP-1-RA or DPP4i
|
Hazard ratio of the composite of myocardial infarction, stroke, hospitalization for unstable angina, or coronary revascularization in individuals with T2DM and overweight with ASCVD, comparing dulaglutide, semaglutide, and tirzepatide vs sitagliptin.
|
Through study completion until first of outcome, disenrollment, end of study period, 365 days after cohort entry, discontinuation (45 days grace and risk window), switch between study arms, nursing home admission, or start of any other GLP-1-RA or DPP4i
|
|
Composite of myocardial infarction, stroke, hospitalization for unstable angina, coronary revascularization, or hospitalization for heart failure (with ASCVD)
Délai: Through study completion until first of outcome, disenrollment, end of study period, 365 days after cohort entry, discontinuation (45 days grace and risk window), switch between study arms, nursing home admission, or start of any other GLP-1-RA or DPP4i
|
Hazard ratio of the composite of myocardial infarction, stroke, hospitalization for unstable angina, coronary revascularization, or hospitalization for heart failure in individuals with T2DM and overweight with ASCVD, comparing dulaglutide, semaglutide, and tirzepatide vs sitagliptin.
|
Through study completion until first of outcome, disenrollment, end of study period, 365 days after cohort entry, discontinuation (45 days grace and risk window), switch between study arms, nursing home admission, or start of any other GLP-1-RA or DPP4i
|
|
Unstable angina (with ASCVD)
Délai: Through study completion until first of outcome, disenrollment, end of study period, 365 days after cohort entry, discontinuation (45 days grace and risk window), switch between study arms, nursing home admission, or start of any other GLP-1-RA or DPP4i
|
Hazard ratio of the occurrence of unstable angina in individuals with T2DM and overweight with ASCVD, comparing dulaglutide, semaglutide, and tirzepatide vs sitagliptin.
|
Through study completion until first of outcome, disenrollment, end of study period, 365 days after cohort entry, discontinuation (45 days grace and risk window), switch between study arms, nursing home admission, or start of any other GLP-1-RA or DPP4i
|
|
Coronary revascularization (with ASCVD)
Délai: Through study completion until first of outcome, disenrollment, end of study period, 365 days after cohort entry, discontinuation (45 days grace and risk window), switch between study arms, nursing home admission, or start of any other GLP-1-RA or DPP4i
|
Hazard ratio of the occurrence of coronary revascularization in individuals with T2DM and overweight with ASCVD, comparing dulaglutide, semaglutide, and tirzepatide vs sitagliptin.
|
Through study completion until first of outcome, disenrollment, end of study period, 365 days after cohort entry, discontinuation (45 days grace and risk window), switch between study arms, nursing home admission, or start of any other GLP-1-RA or DPP4i
|
|
Hospitalization for heart failure (with ASCVD)
Délai: Through study completion until first of outcome, disenrollment, end of study period, 365 days after cohort entry, discontinuation (45 days grace and risk window), switch between study arms, nursing home admission, or start of any other GLP-1-RA or DPP4i
|
Hazard ratio of the occurrence of hospitalization for heart failure in individuals with T2DM and overweight with ASCVD, comparing dulaglutide, semaglutide, and tirzepatide vs sitagliptin.
|
Through study completion until first of outcome, disenrollment, end of study period, 365 days after cohort entry, discontinuation (45 days grace and risk window), switch between study arms, nursing home admission, or start of any other GLP-1-RA or DPP4i
|
|
Time to first hospitalization for any cause (with ASCVD)
Délai: Through study completion until first of outcome, disenrollment, end of study period, 365 days after cohort entry, discontinuation (45 days grace and risk window), switch between study arms, nursing home admission, or start of any other GLP-1-RA or DPP4i
|
Hazard ratio of time to first hospitalization for any cause in individuals with T2DM and overweight with ASCVD, comparing dulaglutide, semaglutide, and tirzepatide vs sitagliptin.
|
Through study completion until first of outcome, disenrollment, end of study period, 365 days after cohort entry, discontinuation (45 days grace and risk window), switch between study arms, nursing home admission, or start of any other GLP-1-RA or DPP4i
|
|
Myocardial infarction (without ASCVD)
Délai: Through study completion until first of outcome, disenrollment, end of study period, 365 days after cohort entry, discontinuation (45 days grace and risk window), switch between study arms, nursing home admission, or start of any other GLP-1-RA or DPP4i
|
Hazard ratio of the occurrence of myocardial infarction in individuals with T2DM and overweight without ASCVD, comparing dulaglutide, semaglutide, and tirzepatide vs sitagliptin.
|
Through study completion until first of outcome, disenrollment, end of study period, 365 days after cohort entry, discontinuation (45 days grace and risk window), switch between study arms, nursing home admission, or start of any other GLP-1-RA or DPP4i
|
|
Stroke (without ASCVD)
Délai: Through study completion until first of outcome, disenrollment, end of study period, 365 days after cohort entry, discontinuation (45 days grace and risk window), switch between study arms, nursing home admission, or start of any other GLP-1-RA or DPP4i
|
Hazard ratio of the occurrence of stroke in individuals with T2DM and overweight without ASCVD, comparing dulaglutide, semaglutide, and tirzepatide vs sitagliptin.
|
Through study completion until first of outcome, disenrollment, end of study period, 365 days after cohort entry, discontinuation (45 days grace and risk window), switch between study arms, nursing home admission, or start of any other GLP-1-RA or DPP4i
|
|
All-cause mortality (without ASCVD)
Délai: Through study completion until first of outcome, disenrollment, end of study period, 365 days after cohort entry, discontinuation (45 days grace and risk window), switch between study arms, nursing home admission, or start of any other GLP-1-RA or DPP4i
|
Hazard ratio of the occurrence of all-cause mortality in individuals with T2DM and overweight without ASCVD, comparing dulaglutide, semaglutide, and tirzepatide vs sitagliptin.
|
Through study completion until first of outcome, disenrollment, end of study period, 365 days after cohort entry, discontinuation (45 days grace and risk window), switch between study arms, nursing home admission, or start of any other GLP-1-RA or DPP4i
|
|
Composite of myocardial infarction, stroke, hospitalization for unstable angina, or coronary revascularization (without ASCVD)
Délai: Through study completion until first of outcome, disenrollment, end of study period, 365 days after cohort entry, discontinuation (45 days grace and risk window), switch between study arms, nursing home admission, or start of any other GLP-1-RA or DPP4i
|
Hazard ratio of the composite of myocardial infarction, stroke, hospitalization for unstable angina, or coronary revascularization in individuals with T2DM and overweight without ASCVD, comparing dulaglutide, semaglutide, and tirzepatide vs sitagliptin.
|
Through study completion until first of outcome, disenrollment, end of study period, 365 days after cohort entry, discontinuation (45 days grace and risk window), switch between study arms, nursing home admission, or start of any other GLP-1-RA or DPP4i
|
|
Composite of myocardial infarction, stroke, hospitalization for unstable angina, coronary revascularization, or hospitalization for heart failure (without ASCVD).
Délai: Through study completion until first of outcome, disenrollment, end of study period, 365 days after cohort entry, discontinuation (45 days grace and risk window), switch between study arms, nursing home admission, or start of any other GLP-1-RA or DPP4i
|
Hazard ratio of the composite of myocardial infarction, stroke, hospitalization for unstable angina, coronary revascularization, or hospitalization for heart failure in individuals with T2DM and overweight without ASCVD, comparing dulaglutide, semaglutide, and tirzepatide vs sitagliptin.
|
Through study completion until first of outcome, disenrollment, end of study period, 365 days after cohort entry, discontinuation (45 days grace and risk window), switch between study arms, nursing home admission, or start of any other GLP-1-RA or DPP4i
|
|
Unstable angina (without ASCVD)
Délai: Through study completion until first of outcome, disenrollment, end of study period, 365 days after cohort entry, discontinuation (45 days grace and risk window), switch between study arms, nursing home admission, or start of any other GLP-1-RA or DPP4i
|
Hazard ratio of the occurrence of unstable angina in individuals with T2DM and overweight without ASCVD, comparing dulaglutide, semaglutide, and tirzepatide vs sitagliptin.
|
Through study completion until first of outcome, disenrollment, end of study period, 365 days after cohort entry, discontinuation (45 days grace and risk window), switch between study arms, nursing home admission, or start of any other GLP-1-RA or DPP4i
|
|
Coronary revascularization (without ASCVD)
Délai: Through study completion until first of outcome, disenrollment, end of study period, 365 days after cohort entry, discontinuation (45 days grace and risk window), switch between study arms, nursing home admission, or start of any other GLP-1-RA or DPP4i
|
Hazard ratio of the occurrence of coronary revascularization in individuals with T2DM and overweight without ASCVD, comparing dulaglutide, semaglutide, and tirzepatide vs sitagliptin.
|
Through study completion until first of outcome, disenrollment, end of study period, 365 days after cohort entry, discontinuation (45 days grace and risk window), switch between study arms, nursing home admission, or start of any other GLP-1-RA or DPP4i
|
|
Hospitalization for heart failure (without ASCVD)
Délai: Through study completion until first of outcome, disenrollment, end of study period, 365 days after cohort entry, discontinuation (45 days grace and risk window), switch between study arms, nursing home admission, or start of any other GLP-1-RA or DPP4i
|
Hazard ratio of the occurrence of hospitalization for heart failure in individuals with T2DM and overweight without ASCVD, comparing dulaglutide, semaglutide, and tirzepatide vs sitagliptin.
|
Through study completion until first of outcome, disenrollment, end of study period, 365 days after cohort entry, discontinuation (45 days grace and risk window), switch between study arms, nursing home admission, or start of any other GLP-1-RA or DPP4i
|
|
Time to first hospitalization for any cause (without ASCVD)
Délai: Through study completion until first of outcome, disenrollment, end of study period, 365 days after cohort entry, discontinuation (45 days grace and risk window), switch between study arms, nursing home admission, or start of any other GLP-1-RA or DPP4i
|
Hazard ratio of time to first hospitalization for any cause in individuals with T2DM and overweight without ASCVD, comparing dulaglutide, semaglutide, and tirzepatide vs sitagliptin.
|
Through study completion until first of outcome, disenrollment, end of study period, 365 days after cohort entry, discontinuation (45 days grace and risk window), switch between study arms, nursing home admission, or start of any other GLP-1-RA or DPP4i
|
|
Urinary tract infections (with ASCVD)
Délai: Through study completion until first of outcome, disenrollment, end of study period, 365 days after cohort entry, discontinuation (45 days grace and risk window), switch between study arms, nursing home admission, or start of any other GLP-1-RA or DPP4i
|
Hazard ratio of the safety outcome of urinary tract infections in individuals with T2DM and overweight with ASCVD, comparing dulaglutide, semaglutide, and tirzepatide vs sitagliptin.
|
Through study completion until first of outcome, disenrollment, end of study period, 365 days after cohort entry, discontinuation (45 days grace and risk window), switch between study arms, nursing home admission, or start of any other GLP-1-RA or DPP4i
|
|
Serious infections (with ASCVD)
Délai: Through study completion until first of outcome, disenrollment, end of study period, 365 days after cohort entry, discontinuation (45 days grace and risk window), switch between study arms, nursing home admission, or start of any other GLP-1-RA or DPP4i
|
Hazard ratio of the safety outcome of serious infections in individuals with T2DM and overweight with ASCVD, comparing dulaglutide, semaglutide, and tirzepatide vs sitagliptin.
|
Through study completion until first of outcome, disenrollment, end of study period, 365 days after cohort entry, discontinuation (45 days grace and risk window), switch between study arms, nursing home admission, or start of any other GLP-1-RA or DPP4i
|
|
Gastrointestinal adverse events (with ASCVD)
Délai: Through study completion until first of outcome, disenrollment, end of study period, 365 days after cohort entry, discontinuation (45 days grace and risk window), switch between study arms, nursing home admission, or start of any other GLP-1-RA or DPP4i
|
Hazard ratio of the safety outcome of gastrointestinal adverse events in individuals with T2DM and overweight with ASCVD, comparing dulaglutide, semaglutide, and tirzepatide vs sitagliptin.
|
Through study completion until first of outcome, disenrollment, end of study period, 365 days after cohort entry, discontinuation (45 days grace and risk window), switch between study arms, nursing home admission, or start of any other GLP-1-RA or DPP4i
|
|
Urinary tract infections (without ASCVD)
Délai: Through study completion until first of outcome, disenrollment, end of study period, 365 days after cohort entry, discontinuation (45 days grace and risk window), switch between study arms, nursing home admission, or start of any other GLP-1-RA or DPP4i
|
Hazard ratio of the safety outcome of urinary tract infections in individuals with T2DM and overweight without ASCVD, comparing dulaglutide, semaglutide, and tirzepatide vs sitagliptin.
|
Through study completion until first of outcome, disenrollment, end of study period, 365 days after cohort entry, discontinuation (45 days grace and risk window), switch between study arms, nursing home admission, or start of any other GLP-1-RA or DPP4i
|
|
Serious infections (without ASCVD)
Délai: Through study completion until first of outcome, disenrollment, end of study period, 365 days after cohort entry, discontinuation (45 days grace and risk window), switch between study arms, nursing home admission, or start of any other GLP-1-RA or DPP4i
|
Hazard ratio of the safety outcome of serious infections in individuals with T2DM and overweight without ASCVD, comparing dulaglutide, semaglutide, and tirzepatide vs sitagliptin.
|
Through study completion until first of outcome, disenrollment, end of study period, 365 days after cohort entry, discontinuation (45 days grace and risk window), switch between study arms, nursing home admission, or start of any other GLP-1-RA or DPP4i
|
|
Gastrointestinal adverse events (without ASCVD)
Délai: Through study completion until first of outcome, disenrollment, end of study period, 365 days after cohort entry, discontinuation (45 days grace and risk window), switch between study arms, nursing home admission, or start of any other GLP-1-RA or DPP4i
|
Hazard ratio of the safety outcome of gastrointestinal adverse events in individuals with T2DM and overweight without ASCVD, comparing dulaglutide, semaglutide, and tirzepatide vs sitagliptin.
|
Through study completion until first of outcome, disenrollment, end of study period, 365 days after cohort entry, discontinuation (45 days grace and risk window), switch between study arms, nursing home admission, or start of any other GLP-1-RA or DPP4i
|
Autres mesures de résultats
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Hernia (with ASCVD)
Délai: Through study completion until first of outcome, disenrollment, end of study period, 365 days after cohort entry, discontinuation (45 days grace and risk window), switch between study arms, nursing home admission, or start of any other GLP-1-RA or DPP4i
|
Hazard ratio of negative control outcome hernia in individuals with T2DM and overweight with ASCVD, comparing dulaglutide, semaglutide, and tirzepatide vs sitagliptin.
|
Through study completion until first of outcome, disenrollment, end of study period, 365 days after cohort entry, discontinuation (45 days grace and risk window), switch between study arms, nursing home admission, or start of any other GLP-1-RA or DPP4i
|
|
Lumbar radiculopathy (with ASCVD)
Délai: Through study completion until first of outcome, disenrollment, end of study period, 365 days after cohort entry, discontinuation (45 days grace and risk window), switch between study arms, nursing home admission, or start of any other GLP-1-RA or DPP4i
|
Hazard ratio of negative control outcome lumbar radiculopathy in individuals with T2DM and overweight with ASCVD, comparing dulaglutide, semaglutide, and tirzepatide vs sitagliptin.
|
Through study completion until first of outcome, disenrollment, end of study period, 365 days after cohort entry, discontinuation (45 days grace and risk window), switch between study arms, nursing home admission, or start of any other GLP-1-RA or DPP4i
|
|
Hernia (without ASCVD)
Délai: Through study completion until first of outcome, disenrollment, end of study period, 365 days after cohort entry, discontinuation (45 days grace and risk window), switch between study arms, nursing home admission, or start of any other GLP-1-RA or DPP4i
|
Hazard ratio of negative control outcomes hernia in individuals with T2DM and overweight without ASCVD, comparing dulaglutide, semaglutide, and tirzepatide vs sitagliptin.
|
Through study completion until first of outcome, disenrollment, end of study period, 365 days after cohort entry, discontinuation (45 days grace and risk window), switch between study arms, nursing home admission, or start of any other GLP-1-RA or DPP4i
|
|
Lumbar radiculopathy (without ASCVD)
Délai: Through study completion until first of outcome, disenrollment, end of study period, 365 days after cohort entry, discontinuation (45 days grace and risk window), switch between study arms, nursing home admission, or start of any other GLP-1-RA or DPP4i
|
Hazard ratio of negative control outcomes lumbar radiculopathy in individuals with T2DM and overweight without ASCVD, comparing dulaglutide, semaglutide, and tirzepatide vs sitagliptin.
|
Through study completion until first of outcome, disenrollment, end of study period, 365 days after cohort entry, discontinuation (45 days grace and risk window), switch between study arms, nursing home admission, or start of any other GLP-1-RA or DPP4i
|
Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Les enquêteurs
- Chercheur principal: Shirley Wang, PhD, ScM, Brigham and Women's Hospital
- Chercheur principal: Nils Kruger, MD, Brigham and Women's Hospital
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Réel)
27 janvier 2026
Achèvement primaire (Estimé)
22 mai 2026
Achèvement de l'étude (Estimé)
22 mai 2026
Dates d'inscription aux études
Première soumission
11 février 2026
Première soumission répondant aux critères de contrôle qualité
11 février 2026
Première publication (Réel)
18 février 2026
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
13 mai 2026
Dernière mise à jour soumise répondant aux critères de contrôle qualité
9 mai 2026
Dernière vérification
1 février 2026
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
- Maladies du système endocrinien
- Troubles nutritionnels
- Maladies métaboliques
- Suralimentation
- Poids
- Troubles du métabolisme du glucose
- Diabète sucré
- Conditions pathologiques, signes et symptômes
- Maladies nutritionnelles et métaboliques
- Signes et symptômes
- En surpoids
- Diabète sucré, Type 2
- Acides aminés, peptides et protéines
- Protéines
- Composés hétérocycliques, 1 anneau
- Composés hétérocycliques
- Azoles
- Récepteur du peptide-1 de type glucagon
- Récepteurs peptidiques de type glucagon
- Récepteurs, G-protéines G
- Récepteurs, surface cellulaire
- Protéines membranaires
- Récepteurs, hormones gastro-intestinales
- Récepteurs, peptide
- Pyrazines
- Triazoles
- Phosphate de sitagliptine
- Tirzépatide
- sémaglutide
- dulaglutide
Autres numéros d'identification d'étude
- 2018P002966-INTERCEPT-ASCVD
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Oui
Étudie un produit d'appareil réglementé par la FDA américaine
Non
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .
Essais cliniques sur Sitagliptine
-
SanofiComplétéSupériorité du glimépiride sur la sitagliptine chez les patients diabétiques de type 2 naïfs (SUMER)Diabète sucré, Type 2Mexique, Guatemala
-
Brigham and Women's HospitalPatient-Centered Outcomes Research Institute; McGill University; VA Boston Healthcare...Actif, ne recrute pasDiabète de type 2 | Maladie rénale | Événements cardiovasculairesÉtats-Unis